[Federal Register Volume 72, Number 240 (Friday, December 14, 2007)]
[Proposed Rules]
[Pages 71083-71086]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-24291]


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 Proposed Rules
                                                 Federal Register
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 This section of the FEDERAL REGISTER contains notices to the public of 
 the proposed issuance of rules and regulations. The purpose of these 
 notices is to give interested persons an opportunity to participate in 
 the rule making prior to the adoption of the final rules.
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  Federal Register / Vol. 72, No. 240 / Friday, December 14, 2007 / 
Proposed Rules  

[[Page 71083]]



NUCLEAR REGULATORY COMMISSION

10 CFR Part 51

[Docket No. PRM-51-11]


Sally Shaw; Denial of Petition for Rulemaking

AGENCY: Nuclear Regulatory Commission.

ACTION: Denial of petition for rulemaking.

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SUMMARY: The Nuclear Regulatory Commission (NRC) is denying a petition 
for rulemaking (PRM) submitted by Sally Shaw on June 23, 2006. The 
petition, docketed as PRM-51-11, requests that the NRC prepare a 
rulemaking to reconcile NUREG-1437, ``Generic Environmental Impact 
Statement for License Renewal of Nuclear Plants'' (May 1996) (GEIS), 
for nuclear power plant operating license renewal applications with the 
National Academy of Sciences' (NAS), ``Health Risks From Exposure to 
Low Levels of Ionizing Radiation: Biological Effects of Ionizing 
Radiation (BEIR) VII, Phase 2,'' Seventh Ed., 2005 report. The 
petitioner believes that this action is necessary because the BEIR VII 
report represents new and significant information on radiation 
standards and risk factors that must be reflected in NRC's GEIS. 
Although the NRC recognizes that the petition highlighted that BEIR VII 
contains a more refined risk assessment based on additional medical 
data and a better dosimetry system, the NRC is denying PRM-51-11 
because it does not provide significant information or arguments that 
were not previously considered by the Commission.

ADDRESSES: Publicly available documents related to these petitions and 
the NRC's letter of denial to the petitioner may be viewed 
electronically on public computers in the NRC's PublicDocument Room 
(PDR), 01 F21, One White Flint North, 11555 Rockville Pike, Rockville, 
Maryland. The PDR reproduction contractor will copy documents for a 
fee. Publicly available documents created or received at the NRC after 
November 1, 1999, are available electronically at the NRC's Electronic 
Reading Room at http://www.nrc.gov/reading-rm/adams.html. From this 
site, the public can gain entry into the NRC's Agencywide Document 
Access and Management System (ADAMS), which provides text and image 
files of NRC's public documents. If you do not have access to ADAMS or 
if there are problems in accessing the documents located in ADAMS, 
contact the PDR reference staff at (800) 387-4209, (301) 415-4737 or by 
e-mail to [email protected].

FOR FURTHER INFORMATION CONTACT: David T. Diec, telephone (301) 415-
2834, e-mail [email protected], or Andrew Luu, telephone (301) 415-1078, e-
mail [email protected], Office of Nuclear Reactor Regulation, Nuclear 
Regulatory Commission, Washington, DC 20555-0001.

SUPPLEMENTARY INFORMATION:

The Petition

    On November 20, 2006 (71 FR 67072), the NRC published a notice of 
receipt of a petition for rulemaking filed by Sally Shaw (the 
petitioner). The petitioner requested that the NRC reconcile the GEIS 
with the NAS BEIR VII report, which was released in 2005. The GEIS 
incorporates data from BEIR V, an earlier NAS report that was released 
in 1990. The NRC regulation, Part 10 of the Code of Federal Regulations 
Section 51.95(c), requires that the NRC prepare a supplemental 
environmental impact statement (SEIS) to the GEIS. The findings of the 
GEIS are set forth in Table B-1 of Appendix B to subpart A of 10 CFR 
part 51 (Table B-1). A copy of the petition can be found in ADAMS under 
accession number ML061770056.
    Specifically, the petitioner requests that the NRC consider the NAS 
BEIR VII report as new and significant information and update the 
radiological impacts and conclusions set forth in the GEIS, including 
early fatalities, latent fatalities, and any injury projections based 
on this information. The petitioner asserts that BEIR VII represents 
the ``current science,'' and states that BEIR VII, unlike BEIR V, 
``estimates risks for cancer incidence rates as well as mortality and 
also provides detailed risk figures according to age of exposure for 
males and females, by cancer type.'' According to the petitioner, BEIR 
VII shows that the cancer mortality risks for women and children are 
much higher than for men. Further, the petitioner asserts that the 
GEIS's radiological impact analysis is calculated based on an 
``arbitrary and false'' threshold dose model, implying that a dose 
received below the threshold would not be of ``regulatory concern.'' In 
this regard, the petitioner refers to BEIR VII, which concludes that 
there is no evidence of a ``threshold dose phenomenon.''
    The petitioner also asserts that the GEIS reports radiation risks 
to nuclear workers of one rem per year based on BEIR V. The petitioner 
requests that these radiation risks be recalculated using BEIR VII and 
the latest science in medical journals, which include exposure to 
internal radiation sources (alpha and beta emitters, via inhalation or 
ingestion). Finally, the petitioner asserts that the radiological 
impact analysis contained in the GEIS assumes that non-stochastic 
effects will not occur if the dose equivalent from internal and 
external sources combined is less than 50 rem per year and, as such, 
must be recalculated in light of BEIR VII.

NRC Evaluation

    The petitioner's request is that the NRC reconcile the GEIS with 
the NAS BEIR VII, 2005 report. The NRC's regulations for implementing 
its responsibilities under the National Environmental Policy Act (NEPA) 
are contained in 10 CFR part 51, ``Environmental Protection Regulations 
for Domestic Licensing and Related Regulatory Functions.'' The renewal 
of a nuclear power plant operating license is identified as a major 
Federal action significantly affecting the quality of the human 
environment, and thus an SEIS (in conjunction with the GEIS) is 
required before the NRC determines whether to approve or disapprove the 
license renewal application. The NRC's requirements for renewal of 
operating licenses for nuclear power plants are contained in 10 CFR 
part 54. The GEIS assesses environmental impacts that could be 
associated with nuclear power plant license renewal and establishes 
generic findings for each type of environmental impact covering as many 
plants as possible. The GEIS reflects the NRC's findings regarding 
those environmental impacts associated with

[[Page 71084]]

license renewal that are well understood.

GEIS

    The GEIS assesses the various environmental impacts associated with 
license renewal in terms of significance and assigns one of three 
significance levels to a given impact--small, moderate, or large. A 
small impact means that the environmental effects are not detectable or 
are so minor that they will neither destabilize nor noticeably alter 
any important attribute of the resource. For the purpose of assessing 
radiological impacts, the NRC has concluded that those impacts that do 
not exceed permissible levels in the NRC's regulations are considered 
small. A moderate impact means that the environmental effects are 
sufficient to alter noticeably but not to destabilize important 
attributes of the resource. A large impact means that the environmental 
effects are clearly noticeable and are sufficient to destabilize 
important attributes of the resource.
    In addition to determining the significance of environmental 
impacts associated with license renewal, the NRC determines if its 
analysis can be applied to all plants and whether additional mitigation 
measures would be warranted. The GEIS sets forth two categories: 
Category 1 and Category 2. Category 1 means that the GEIS analysis has 
shown that the environmental impacts associated with the issue have 
been determined to apply either to all plants or, for some 
environmental issues, to plants having a specific type of cooling 
system or other specified plant or site characteristics; a single 
significance level (i.e., small, moderate, or large) has been assigned 
to the impacts; mitigation of adverse impacts associated with the issue 
has been considered in the analysis; and it has been determined that 
additional plant-specific mitigation measures are not likely to be 
sufficiently beneficial to warrant implementation. Category 2 means 
that the GEIS analysis does not meet the criteria of Category 1, and 
thus, on that particular environmental issue, additional plant-specific 
review is required. The GEIS findings are set forth in Table B-1 of 
Appendix B to subpart A of 10 CFR part 51.
    For each license renewal application, the NRC will prepare a draft 
SEIS to analyze those plant-specific (Category 2) issues. The SEIS is 
not required to cover any Category 1 issues. The draft SEIS is made 
available for public comment. After consideration of any public 
comments, the NRC will prepare and issue a final SEIS under 10 CFR 
51.91 and 51.93. The final SEIS and the GEIS serve as the requisite 
NEPA analysis for any given license renewal application.
    The GEIS analysis, as shown in Table B-1, concluded that both 
public and occupational radiation exposures during any plant 
refurbishment or plant operation through the license renewal term are 
of a small significance level and meet all Category 1 criteria. This 
conclusion is based on a given licensee's adherence to, and if 
necessary, NRC enforcement of, the dose limits as required in 10 CFR 
part 20, ``Standards for Protection Against Radiation'' and in Appendix 
I to 10 CFR part 50, ``Numerical Guides for Design Objectives and 
Limiting Conditions for Operation to Meet the Criterion `As Low As Is 
Reasonably Achievable' (ALARA) for Radioactive Material in Light-Water-
Cooled Nuclear Power Reactor Effluents.'' Regulations at 10 CFR part 20 
require that a licensee limit the annual dose to a member of the public 
to no more than 0.1 rem (1mSv) total effective dose equivalent (TEDE). 
In addition, 40 CFR part 190, ``Environmental Radiation Protection 
Standards For Nuclear Power Operations,'' further restricts the 
allowable annual dose to a member of the public to a lower value of 
0.025 rem (0.25 mSv) and to maintain doses to members of the public 
that are ALARA. Finally, 10 CFR 50.34a requires a nuclear power plant 
to maintain control over radioactive gaseous and liquid effluents 
produced during normal operations to dose levels contained in Appendix 
I to 10 CFR Part 50, which are in the range of 0.003 rem (0.03 mSv) to 
0.005 rem (0.05 mSv).

BEIR Reports

    The risk estimates of human health effects from radiation were 
first evaluated by scientific committees starting in the 1950s. Since 
1972, the National Academy of Sciences has published a series of 
reports on the biological effects of ionizing radiation (the BEIR 
reports), including the BEIR V report in 1990 and the BEIR VII report 
in 2005. The BEIR V and BEIR VII reports concentrated primarily on 
providing a comprehensive review of all biological and biophysical data 
regarding the health effects attributable to exposures to low doses of 
ionizing radiation, ranging between 0 to 10 rem (0-100 mSv). Although 
the BEIR VII committee examined several sources of epidemiological data 
(i.e., medical and occupational exposures), the single most important 
source of epidemiological data is the cohort of 120,000 Japanese atomic 
bomb survivors from the cities of Hiroshima and Nagasaki.
    Three major changes have occurred after the BEIR V report was 
published. First, an additional 12 years of follow-up medical data are 
available. Second, cancer incidence data for the cohort are available 
(for BEIR V, only mortality data were available). The impact of these 
two developments has reduced the uncertainty in the assessment of 
cancer risk among the atomic bomb survivors. Third, the dosimetry 
system used to assign radiation exposure to the atomic bomb survivors 
was replaced with an improved dosimetry system. These changes have 
improved our understanding of the health risks associated with 
radiation exposure. The overall risk estimates of the BEIR V and BEIR 
VII reports, however, remain statistically insignificant. In this 
regard, the BEIR VII report states: ``in general the magnitude of 
estimated risks for total cancer mortality or leukemia has not changed 
greatly from estimates in past reports such as BEIR V and recent 
reports of the United Nations Scientific Committee on the Effects of 
Atomic Radiation (UNSCEAR) and the International Commission on 
Radiological Protection (ICRP). New data and analyses have reduced 
sampling uncertainty, but uncertainties related to estimating risk for 
exposure at low doses and dose rates and transporting risks from 
Japanese A-bomb survivors to the U.S. population remain large. 
Uncertainties in estimating risks of site-specific cancers are 
especially large.''
    The NRC staff completed a review of the BEIR VII report and 
documented its findings in the Commission paper SECY-05-0202, ``Staff 
Review of the National Academies Study of the Health Risks from 
Exposure to Low Levels of Ionizing Radiation (BEIR VII),'' dated 
October 29, 2005 (ADAMS accession number ML052640532). In this paper, 
the NRC staff concluded that the findings presented in the BEIR VII 
report agree with the NRC's current understanding of the health risks 
from exposure to ionizing radiation. The BEIR VII report's major 
conclusion is that current scientific evidence is consistent with the 
hypothesis that there is a linear, no-threshold dose response 
relationship between exposure to ionizing radiation and the development 
of cancer in humans. This conclusion is consistent with the system of 
radiological protection that the NRC used to develop its regulations 
and the GEIS. Therefore, the NRC's regulations and the GEIS continue to 
be adequately protective of public health and safety and the 
environment. Consequently, none of the findings in the BEIR VII

[[Page 71085]]

report represent new and significant information when compared to the 
findings of the BEIR V report and thus, there is no need to amend NRC 
regulations or the GEIS. The NRC has determined that a specific 
rulemaking to amend 10 CFR Part 51 and by extension, the GEIS, is not 
warranted.

Public Comments

    The NRC received a total of 74 public comments relating to this 
petition. Of the 74 comments, 69 supported granting the petition. No 
comments opposed the petition and five comments were not applicable to 
this petition. The letters in support of the petition were essentially 
identical and contained one or more of the following four assertions:
    A. Protect the most vulnerable populations in the regulatory 
standards.
    B. Recognize that ``allowable'' levels are not safe.
    C. Consider radiation damage from inhaling or ingesting 
radionuclides; and
    D. Recognize that there is no safe dose.

A. Protect the Most Vulnerable Populations in the Regulatory Standards

    Although some epidemiological studies have shown that children, 
individuals in poor health, and the elderly are more radiosensitive to 
radiation at high doses and high dose rates, no adverse health effects 
have been observed in these populations at the doses associated with 
NRC's radiation protection regulations and standards. The NRC, in NUREG 
1850, ``Frequently Asked Questions on License Renewal of Nuclear Power 
Reactors,'' provides information on a number of studies that have been 
performed to examine the health effects around nuclear power 
facilities. These studies report that there is no conclusive evidence 
which shows a statistical correlation between the low level radiation 
dose received by members of the public living near a nuclear power 
plant and their cancer incidence.
    The dose from radioactive gaseous and liquid effluents is based on 
the ``maximum exposed individual'' and calculated to each of the four 
age groups (0-1, 1-11, 11-17, and 17 years and older). The methodology 
and guidance for calculating these doses and the associated dose 
conversion factors for each age group, are contained in Regulatory 
Guide 1.109, ``Calculation of Annual Doses to Man from Routine Releases 
of Reactor Effluents for the Purpose of Evaluating Compliance with 10 
CFR Part 50, Appendix I.'' Nuclear power reactors implement this 
methodology and guidance in individual plant radiation protection 
programs and operating procedures. The NRC has concluded that the 
current NRC radiation protection standards continue to ensure adequate 
protection of the public. This position is further reiterated in the 
Commission Paper SECY-05-0202. In this paper, the NRC staff reviewed 
and evaluated NRC's radiation safety regulations and standards against 
the findings of the BEIR VII report. The NRC staff concluded ``that the 
findings presented in the National Academies BEIR VII report contribute 
to our understanding of the heath risks from exposure to ionizing 
radiation. The major conclusion is that current scientific evidence is 
consistent with the hypothesis that there is a linear, no-threshold 
dose response relationship between exposure to ionizing radiation and 
the development of cancer in humans.'' The BEIR VII report's conclusion 
is consistent with the system of radiological protection that the NRC 
used to develop its regulations and the GEIS. Therefore, the NRC 
concludes that the current regulations continue to be adequately 
protective of the public health and safety and the environment. 
Consequently, none of the findings in the BEIR VII report warrant 
initiating any immediate change to NRC regulations or the GEIS.

B. Recognize That ``Allowable'' Levels Are Not Safe

    Commenter states that these levels are based on obsolete ``standard 
man,'' concept that applies to a healthy, white male in the prime of 
his life, and ignore the more vulnerable fetus, growing infant, 
children, and women who, according to the BEIR VII report, are 37-50 
percent more vulnerable than men to the harmful effects of ionizing 
radiation. Although some epidemiological studies have shown that 
children, individuals in poor health, and the elderly are more 
radiosensitive to radiation at high doses and high dose rates, no 
adverse health effects have been observed in these populations at the 
doses associated with NRC's radiation protection regulations and 
standards. The amount of radioactive material released from nuclear 
power facilities is well measured, closely monitored, and known to be 
very small. As shown by the studies referenced in NUREG-1850, the 
radiation dose received by members of the public from the normal 
operation of a nuclear power plant are so low that no cancers have been 
observed.
    The BEIR VII committee's preferred estimate of lifetime 
attributable risk for solid cancer incidence and mortality (Tables 12-
13) suggest that females are more sensitive than males to radiation 
exposure at 10 rem, a level that is 100 times the NRC's radiation 
protection standards specified in 10 CFR Part 20. The BEIR VII 
committee's preferred estimate of lifetime attributable risk for 
leukemia cancer incidence and mortality (Tables 12-13), moreover, 
suggest that males are more sensitive than females. The BEIR VII 
committee uses the 95 percent confidence intervals associated with 
estimated lifetime cancer risk for males and females that suggest that 
the apparent gender difference may not be statistically significant. 
Consequently, the BEIR VII report combined the two risk estimates and 
cited an average value which was also done by the BEIR V committee. A 
potential gender difference was not discussed in the BEIR VII report.
    The NRC radiation protection regulation, 10 CFR 20.1208, requires 
each licensee to ensure that the dose equivalent to the embryo/fetus 
during the entire pregnancy, due to the occupational exposure of a 
declared pregnant woman, does not exceed 0.5 rem (5 mSv). These 
radiation protection standards continue to ensure adequate protection 
of the public health and safety and the environment.
    The petitioner has also requested that the NRC review an article 
entitled ``Healthy from the Start: Building a Better Basis for 
Environmental Health Standards--Starting with Radiation,'' published by 
the Institute for Energy and Environmental Research (IEER), February 
2007. This article was not published in a scientific peer-reviewed 
journal and the article's conclusions do not appear to have been 
subjected to an independent peer review process. The authors of this 
article have stated that there are cause-and-effect relationships in 
the statistical associations between cancer rates and nuclear power 
reactor operations. Although it is true that cancer rates vary among 
locations, it is difficult to ascribe the cause of a cluster of cancers 
to a specific environmental agent, such as radiation from a nuclear 
power plant. Statistical association alone does not demonstrate 
causation. Also, well-established scientific methods must be used to 
demonstrate that these causal effects are appeared to be associated 
over time. Discussions regarding infants, children, and women are 
addressed in section A of this document.

C. Consider Radiation Damage From Inhaling or Ingesting Radionuclides

    The issue of radiation risks, as discussed in the GEIS (i.e., 
Appendix E, section E 4.1.1), used a reference value of 1 rem to 
calculate the estimated

[[Page 71086]]

number of excess cancer fatalities, based on the BEIR V report. As 
discussed in the section titled, ``BEIR Reports,'' while the changes 
between the reports has increased our understanding of radiation risk, 
none of the findings of the BEIR VII report represent new and 
significant information when compared to the findings of the BEIR V 
report. Thus, there is no need to amend NRC regulations or the GEIS.
    Human health effects associated with ionizing radiation, which the 
GEIS classifies as a Category 1 issue, are divided into two broad 
categories, non-stochastic and stochastic. The non-stochastic health 
effects are those in which the severity varies in direct relationship 
with the radiation dose and for which, according to scientific reports 
from ICRP, UNSCEAR, as well as the BEIR committee, a dose threshold is 
known to exist. Radiation-induced cataract formation is an example of a 
non-stochastic effect. The stochastic health effects are those that 
occur randomly and for which the probability of the effect occurring, 
rather than its severity, is assumed to be a linear function of dose 
without threshold. Hereditary effects and cancer incidences are 
examples of stochastic effects. For the mitigation of stochastic health 
effects, the NRC endorses the linear, no-threshold dose response model 
as a basis for its radiation protection standards. This model indicates 
that any increase in radiation dose, no matter how small, results in an 
incremental increase in the risk of adverse health effects.
    NRC regulations and standards, such as the annual dose limits 
contained in 10 CFR Part 20 for members of the public and for 
occupational workers, account for stochastic and non-stochastic health 
effects of radioactive material inhaled or ingested into the human 
body. For members of the public, the annual dose limit from exposure to 
radiation from an NRC licensed facility is 0.1 rem. For occupational 
workers, there are specific dose limits to address the stochastic and 
non-stochastic health effects. The total effective dose equivalent 
limit which addresses the stochastic health effects is limited to an 
annual dose of 5 rem. To address the non-stochastic health effects, the 
annual dose limit to any individual organ or tissue and the skin, other 
than the lens of the eye, is 50 rem; the annual dose limit to the lens 
of the eye is 15 rem. The dose unit is specified as TEDE in rem. The 
TEDE dose is the sum of the deep-dose equivalent (i.e., external 
exposures) and the committed effective dose equivalent (i.e., internal 
exposures received from inhaling or ingesting of radioactive material 
which includes alpha, beta, gamma, and neutron emitters). The current 
dose regulations and standards contain adequate radiation safety limits 
based on radiation exposures from all types of radioactive material and 
therefore, continue to ensure adequate protection of the public and 
occupational workers.
    Further, Appendix I to 10 CFR Part 50 provides numerical ALARA dose 
criteria for the discharge of radioactive gaseous and liquid effluents 
from nuclear power plants. These dose objectives are incorporated into 
each nuclear power plant's license conditions. The NRC collects and 
assesses data regarding licensees' adherence to regulations based on 
site visits, audits and inspection records, and the annual radiological 
effluent release reports required to be submitted to the NRC and 
concludes that nuclear power plants continue to maintain their 
radioactive effluents to the ALARA dose criteria.

D. Recognize That There Is No Safe Dose

    The BEIR VII report's major conclusion is that current scientific 
evidence is consistent with the hypothesis that there is a linear, no-
threshold dose response relationship between exposure to ionizing 
radiation and the development of cancer in humans. The BEIR VII 
committee did not attempt to equate radiation exposure and safety, nor 
did it offer any judgment or opinion on what constitutes a safe level 
of radiation exposure. It concludes that establishing limits on public 
exposure to ionizing radiation is the responsibility of Federal 
agencies like the U.S. Environmental Protection Agency and the NRC. The 
linear, no-threshold dose response relationship between exposure to 
ionizing radiation and the development of cancer in humans is 
consistent with the system of radiological protection that the NRC uses 
as a basis to develop its regulations. Therefore, the NRC's regulations 
continue to ensure adequate protection of the public health and safety 
and the environment.

Reasons for Denial

    The Commission is denying the petition for rulemaking submitted by 
Sally Shaw. The specific issues contained in the petition are already 
adequately addressed in the NRC's radiation protection regulations and 
standards.
    Although this petition is being denied, the Commission notes that 
the current GEIS that referenced the BEIR V, 1999 report, is undergoing 
planned revision and will consider recent radiological studies, 
including the BEIR VII, 2005 report. The summary of findings as a 
result of the planned update will be codified through an ongoing and 
routine rulemaking to 10 CFR Part 51, Subpart A, Appendix B, Table B1--
Summary of Findings on NEPA Issues for License Renewal of Nuclear Power 
Plants.
    The Commission has concluded that nuclear plants that are in 
compliance with NRC radiation protection regulations and standards 
remain protective of public health and safety and the environment. The 
radiological health and environmental impacts contained in the GEIS, 
which are based on regulatory compliance, remain valid.
    For these reasons, the Commission denies PRM-51-11.

    Dated at Rockville, Maryland, this 10th day of December 2007.

    For the Nuclear Regulatory Commission.
Annette L. Vietti-Cook,
Secretary of the Commission.
 [FR Doc. E7-24291 Filed 12-13-07; 8:45 am]
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